Sr. Engineer/Scientist, Quality Systems position at LifeCell Corporation in Branchburg

LifeCell Corporation is at present recruited Sr. Engineer/Scientist, Quality Systems on Mon, 11 Mar 2013 23:45:10 GMT. LifeCell Corporation develops and markets tissue repair products for use in reconstructive, urogynecologic and orthopedic surgical procedures. LifeCell's leading technologies include: Strattice™, for reconstructive and general surgical procedures; and AlloDerm®, for plastic reconstructive, general surgical, burn and periodontal procedures and Cymetra®, a particle form of AlloDerm suitable for...

Sr. Engineer/Scientist, Quality Systems

Location: Branchburg New Jersey

Description: LifeCell Corporation is at present recruited Sr. Engineer/Scientist, Quality Systems right now, this position will be placed in New Jersey. More complete informations about this position opportunity kindly see the descriptions. LifeCell Corporation develops and markets tissue repair products for use in reconstructive, urogynecologic and orthopedic surgical procedures. LifeCe! ll's leading technologies include: Strattice™, for reconstructive and general surgical procedures; and AlloDerm®, for plastic reconstructive, general surgical, burn and periodontal procedures and Cymetra®, a particle form of AlloDerm suitable for injection.

LifeCell's patented tissue matrix was developed in 1994 as a graft for burn patients. Since then, AlloDerm's versatility has led to its use in many other reconstructive applications, allowing surgeons to restore tissue damaged through injury or disease - using the regenerative power of the patients' own tissues.

Nearly 15 years of successful use has proven AlloDerm's exceptional versatility, with new applications to be discovered. In 2008, LifeCell launched Strattice, a Regenerative Tissue Matrix to assist surgeons and their patent with the repair of soft tissue defects. Today, our patented tissue matrix technology remains "first in class" - making LifeCell the leader in tissue regeneration.
LifeCell Corporation

Position Summary: The S! r. Engineer/Scientist, Quality Systems reports to the Sr. Manager, Quality Systems. The Sr. Engineer/Scientist, Quality Systems

is responsible for identifying, planning, reviewing, and tracking improvements to companywide Quality Systems. This is done by partnering with Quality System functional owners, benchmarking processes relative to industry leaders, leading the Quality System Management System Review process, and developing/managing the overall Quality System integration plan. The incumbent is ultimately responsible for planning and leading essential daily and project oriented activities related to Quality Systems Policy & Procedures and Quality System Management Review in support of the overall Quality, Regulatory, and Tissue Services strategy.

Primary Duties/Responsibilities:
Facilitates implementation of the global strategy for the Quality Management System (QMS) to ensure compliance, process integration, and drive a competitive advanta! ge. Identifies process needs to ensure the Quality Management System is prepared for global expansion, new product introduction, and continuous improvement.

Cultivates strong internal partnerships to proactively involve key stakeholders and identify opportunities for QMS improvement. Facilitate forums and other internal meetings to provide/gather feedback on the state of the QMS and foster companywide involvement.

Facilitates the Quality System Management Review (QSMR) process including goal setting, meeting facilitation, and continuous tracking of key performance metrics for the QMS throughout the LifeCell organization.

Maintain a thorough understanding of the following regulations and guidelines: FDA Good Manufacturing Practices, FDA Good Tissue Practices, AATB Good Tissue Practices, state regulations, ISO 9001, ISO 13485, ISO 14971 standards, LifeCell corporation policies and procedures, 93/42 EEC Medical Device Directive, and other applicable ! standards.

Maintain a thorough working knowledge of current an! d best industry practice within the applicable global regulations and standards to ensure appropriate strategy and best compliance. Actively participate in industry groups/forums to understand future changes. Identifies emerging compliance trends and significant events to direct management with a sense of urgency.

Qualifications

Required Qualifications:
Bachelor's degree in a Medical, Technical, Engineering or related field is required.

5-7 yrs Individual contributor experience in Regulatory/Quality for medical devices

Other Required Skills

:

• 5-7 years experience in regulatory/quality management, including management of staff members. Excellent interpersonal skills.
• Experience in Quality Systems in medical device industry.
• Exceptional Technical Writing and analytical skills and minimum 3 years experience in an FDA regulated industry. Solid knowledge of cGTP, GMP, GCP, and/or QSR regu! lations and/or ISO 9001 and 13485 Quality Management System Standards.
• Proven ability to communicate effectively, orally, and in writing. Excellent computer skills required. Proven ability to maintain confidentiality and discretion in business relationships and exercise sound business judgement.
• Basic data analysis and statistical analysis skills. Ability to use/create databases and prepare documents.
• Must be able to prioritize work for self and others. Must be able to work independently on routine tasks. Is able to prioritize tasks to meet deadlines.

Preferred Qualifications

:

• Direct Regulatory Agency interactions
• Demonstrated experience with diverse groups including management at all levels.
• Willing to travel both domestically and internationally, as needed.

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If you were eligible to this position, please email us your resume, with salary requirements and a resume! to LifeCell Corporation.

If you interested on this position just click on the Apply button, you will be redirected to the official website

This position starts available on: Mon, 11 Mar 2013 23:45:10 GMT

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